Point-of-care (POC) testing, also known as near-patient testing (NPT), refers to medical analytic testing of patient specimens at or near the location of patient care, including such testing in the immediate vicinity of the patients, so called bedside testing. POC testing can replace conventional centralized laboratory analysis by using distributed easy-to-operate POC devices, which may be operated by non-laboratory persons and in non-laboratory environments. Such devices constitute a new device class, POC analytic devices.
Advantages with clinical POC testing include; reduced risk of pre-analytical errors due to the immediateness of the analysis, the non-necessity of anticoagulation and reduced risk of erroneous labeling. In addition the immediate availability of analytical results, including the greater patient involvement, can increase the quality the patients experience in the contact with the health care organization, and improved treatment, including more rapid implementation of medical treatment. POC testing also makes the use of health care premises and personnel more efficient.
During the past decades there has been a considerable increase in the numbers of clinical POC devices in use at health facilities, but many of the devices are incapable of communicating with electronic patient information management systems. Electronic patient information management systems are also referred to as “laboratory information systems”, LIS, or “health care information systems”, HIS. During the same time period, there has been an increased desire towards increased use of electronic patient information management systems. Hence, there is an increased desire to transfer results from POC devices to such systems, for several reasons.
Many POC analytic devices in use are designed to present the results to the user on a display, and to print the results using a dedicated printer. The result therefore needs to be transcribed and entered manually, by keyboard, when storage of the result in electronic patient information management system is required. In connection with the transcription of an analytical result, the identity of the sample, or the patient, also needs to be transcribed into the patient information system. One example of this type of conventional POC analytic device is the present applicant's product Simple Simon® PT, which analyses blood samples and determines prothrombin time (PT).
With clinical analytic devices, where the patient identity is not directly connected with the analytical result, there is a risk that the connection between the result and the patient identity is lost, or confused with another patient's identity, before entering both into the electronic information management system. Also, the result may be erroneously transcribed. In fact, it has turned out that a significant percentage of results from POC testing that have been communicated to patients at the POC are not the same as the results that actually become entered into the electronic patient information management system. This has been revealed when patients later have been formally communicated the test result, e.g. by letter.
Another problem is traceability, i.e. which POC analytic device individual has been used in a test etc, which thus requires identity of the POC analytic devices to be stored as well. Such requirement adds an additional burden when also the device identity has to be transcribed, and as a result the entered identity is in practice often connected with errors, or is neglected. One solution to these problems is to replace the presently used POC devices with upgraded devices which will perform the desired tasks. The upgraded versions e.g. would 1) allow the identity of the sample or patient to be entered into its computer memory, 2) have the analytical result entered into its computer memory, 3) link the sample, or patient, identity to the analytical result, and 4) communicate the linked data, by use of the necessary communications protocol, to an electronic patient information management system.
Several POC analytic devices come in two models, one, still the more common, not adapted for connectivity to an electronic patient information management system, and another, upgraded version, adapted for use with such systems. For example HemoCue® models Hb 201+ and Hb 201 DM, where the former stores results which can be printed directly via an external printer or downloaded to a PC, while the latter can be made to also prompt the operator for supplementary data, i.e. patient identification and other information, and to transmit the complete data set, including, of course, the test result, to an electronic information system. Other such duos, one model non-connectable the other upgraded to connectivity, are: Orion's Quick Read 101 CRP (connectable only with accessory) and Quick Read Go, EKF's Hemocontrol and Hemocontrol Manager, Bodi's i-Chroma CRP and i-Chroma Duo, Vital's MicroSed R and Exite 20 and Macherey-Nagel's Uryxxon Relax and Uryxxon 500.